2nd Edition of Cell & Gene Therapy World Conference 2026

Abstract

Advanced cell and gene therapies depend fundamentally on the quality, stability, and scalability of the starting materials 'Plasmid DNA'. As vector and mRNA complexity increases and programs transition from early development to commercial manufacturing, the need for reproducible, inspection-ready plasmid platforms has become increasingly critical. This presentation will outline how an integrated, next-generation plasmid manufacturing strategy can fasten development timelines while helping with regulatory confidence and long-term commercial viability of therapeutic developers programs. Bionova Scientific, founded in 2014 and now part of the Asahi Kasei bioprocessing network, operates within a global ecosystem spanning Japan, Europe, and the United States. Central to this strategy is a purpose-built plasmid DNA facility in The Woodlands, Texas, designed to bridge R&D through GMP production using standardized processes and scalable infrastructure. Expansion plans toward commercial-scale further reinforce this long-term commitment to capacity and reliability. A key differentiator of the platform is the implementation of an insertion-sequence-free (IS-Free) Clean-Genome® E. coli host system. Traditional E. coli strains contain mobile genetic elements that can compromise plasmid integrity, particularly in complex lentiviral vector backbones. Removal of these unstable elements enhances genetic stability, improves batch-to-batch consistency, and reduces manufacturing risk factors that are increasingly scrutinized in regulatory review. By aligning plasmid design, process scalability, and quality governance from the outset, advanced therapy developers can reduce technical risk, improve cost-of-goods profiles, and accelerate the path from concept to clinic and ultimately to patients